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Docusate Sodium Liquid Docusate Sodium.50mg/5mL 50 mg/5mL Solution — NDC 73564-813-16 (Billing 73564-0813-16)

by Aldama Pharmaceuticals, Inc · 1 BOTTLE in 1 BOX / 473 mL in 1 BOTTLE

This is a package of Docusate Sodium Liquid Docusate Sodium.50mg/5mL 50 mg/5mL Solution from Aldama Pharmaceuticals, Inc, marketed since Jun 2026 and currently FDA-listed. It is this product's only package size.

NDC 73564-0813-16
🏷️ FDA NDC (as labeled) 73564-813-16 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 20, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 73564-813-16
Product NDC 73564-813
11-digit billing NDC 73564081316
RxCUI 1245686
UNII F05Q2T2JA0
UPC 0898254002518
Application # M007
SPL Set ID 492b6d37-47cf-3a28-e063-6294a90a2a18
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-01
Route ORAL
Dosage form SOLUTION
Substance DOCUSATE SODIUM
Quick answers
  • RxCUI (RxNorm): 1245686
Why two NDCs? The FDA registers this code as 73564-813-16 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 73564-0813-16. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Softeners, emollients class.

Drug family (ATC) Softeners, emollients
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 About the active ingredient: Docusate Sodium MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Stool softeners are used on a short-term basis to relieve constipation by people who should avoid straining during bowel movements because of heart conditions, hemorrhoids, and other problems. They work by softening stools to make them easier to pass.

Read the full MedlinePlus article ↗
🧪 What is this product?

This is an over-the-counter oral liquid containing docusate sodium, a stool softener. Docusate sodium is typically used to help ease bowel movements by softening stool, and is commonly taken to relieve occasional constipation. The product is marketed as an OTC monograph drug, meaning it is sold under the FDA's established rules for this class of over-the-counter products rather than through an individual application review.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
73564-0813-16 You're viewing this Main listing 1 BOTTLE in 1 BOX / 473 mL in 1 BOTTLE 2026-06-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Docusate Sodium 50 mg/5mL 00121-0935-16 PAI 473 ml $0.021 — Discontinued —
Docusate Sodium 100 mg/10mL 00121-1870-00 PAI 10 cups — — FDA listed —
Docusate Sodium 100 mg/10mL 00904-7279-72 Major 10 cups — — FDA listed —
Docusate Sodium 50 mg/5mL 55154-2346-05 Cardinal 5 cups — — FDA listed —
Docusate Sodium 100 mg/10mL 60687-0878-56 American 10 cups — — FDA listed —
Docusate Sodium Liquid 50 mg/5mLthis 73564-0813-16 Aldama 1 bottle — — FDA listed —
Curewell Docusate Sodium Liquid 50 mg/5mL 85111-0403-16 RMT 1 bottle — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
Jun 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAldama Pharmaceuticals, Inc
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code73564
First marketedJun 2026
Product typeHuman Otc Drug
Portfolio8 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 5 words ▾

Uses Relief of occasional constipation

⏱️ Dosage and Administration 70 words ▾

Directions follow dosing directions below or use as directed by a physician must be give in a 6 oz to 8 oz glass of mil or fruit juice to prevent throat irritation may be taken as a single daily dose or in dividend dose take maximum dose daily until first bowel movement dosage should the be reduced according to individual response do not exceed recommende dose shake well before using

⚠️ Warnings 23 words ▾

Warnings abdominal pain, nauseas, or vomiting are present unless directed by a doctor for more than one week unless directed by a doctor

🧪 Active Ingredient 9 words ▾

Active ingredient (in each 5 mL-teaspoonful) Docusate Sodium 50mg

🧪 Inactive Ingredients 18 words ▾

Inactive Ingredient flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate and sucralose

🎯 Purpose 3 words ▾

Purpose Stool Softener

📄 Do Not Use 25 words ▾

Do not use abdominal pain, nauseas, or vomiting are present unless directed by a doctor for more than one week unless directed by a doctor

📄 Ask a Doctor Before Use If 25 words ▾

Ask a doctor before use if you are taking mineral oil have noticed a sudden change in bowel habits that last more than two weeks

📄 Ask a Doctor or Pharmacist Before Use If 35 words ▾

Stop use and ask a doctor if you have no bowel movements withing 3 days you have rectal bleeding these could be signs of a seriuos condition a skin rash occurs you experience throat irritation

🤰 If Pregnant or Breast-Feeding 9 words ▾

If pregnant or breast-feeding ask a doctor before use

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children. In case of overdose, seek medical assistance or contact a Poison Control Center (1-800-222-1222) right away.

📄 Other Information 60 words ▾

Other information TAMPER EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing store at room temperature between 20-25°C (68-77°F) Permitted excursions between 15-30°C (59-86°F) protect from excessive heat Pharmacist:: preserve and dispense in a tight light, light-resistant container with a child-resistant cap as defined in the UPS each teaspoon (5ml) contains sodium 5 mg

📄 Questions or Comments 6 words ▾

Question or Comments? 305-592-9216 or [email protected]

📄 Package Label / Principal Display Panel 1 words ▾

label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Docusate Sodium Liquid (this brand).

Top reported reactions

Nausea1,623
Fatigue1,592
Dyspnoea1,398
Constipation1,226
Diarrhoea1,225
Vomiting1,192
Pain1,170

Age at onset

Neonate10
Infant19
Child23
Adolescent33
Adult1,419
Elderly1,750

Reporter sex

20,329 reports
Male · 43%
Female · 56%
Unknown · 0%

Serious outcomes

Hospitalization9,623
Death2,787
Life-threatening1,214
Disabling800
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,736 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Aldama Pharmaceuticals, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Aldama Pharmaceuticals, Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 73564-0812-08 · Aldama 73564-0814-16 · Aldama →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.